TriangleNCT02122185 · OUTCOME
Number of Participants With Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 years
What was measured
Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Groups in this outcome
Metformin Plus Chemotherapy
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
Placebo Plus Chemotherapy
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
| Group | Source count |
|---|---|
| Metformin Plus Chemotherapy | 54 |
| Placebo Plus Chemotherapy | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Metformin Plus Chemotherapy | 19 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Chemotherapy | 13 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.29
- p Value Comment
- Two-sided.
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.29
- p Value Comment
- Two-sided.
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
- groups
- description
- Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
- id
- OG000
- title
- Metformin Plus Chemotherapy
- description
- Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
- id
- OG001
- title
- Placebo Plus Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 6 years
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice